The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for compounding solutions for intravascular

FDA device recall Z-1371-2012 · posted 2012-04-05 · Terminated

Recall details

Recalling firm

Baxa Corporation

Reason for recall

Remote possibility of an unintended ingredient delivery as a result of a damaged valve actuator on the EM 2400.

Action taken

The firm, Baxa, sent a "Exacta-Mix 2400 Compounder Safety Alert" dated June 3, 2008 to all customers. The alert describes the product, problem and actions to be taken. The customers were instructed to not use the main module if any of the 24 valve actuators are damaged; do not infuse any bags if damage is noticed after they have been pumped; do not try to repair or adjust a damaged or bent valve actuator; immediately alert all compounder users of this issue to ensure that when the device is used, the valve actuators are always inspected for damage;" inspect all valve acutators before setup and after tear-down to ensure they are not damaged or bent. Do not use the compounder if the valve actuators are damaged or bent."; and if a damaged or bent valve is noticed after using the EM2400, immediately hold all pumped bags and contact Baxa Technical Support. If you need additional assistance, please contact Baxa Technical Support (800-678-2292). Technical Support is available 24 hours a day, 7 days a week.

Root cause

Device Design

Status

Terminated

Product code

NEP

Quantity affected

1000 units (approximately)

Distribution

Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, China, New Zealand, and United Kingdom.

Date initiated

2008-06-03

Date posted

2012-04-05

Date terminated

2012-04-10

Location

Englewood, CO